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Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only.

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The provided text is a 510(k) clearance letter from the FDA for an "Oximeter Pre-AMP Cable." This document primarily grants marketing clearance for the device based on its substantial equivalence to a predicate device.

It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined. The FDA letter is a regulatory approval, not a performance study report.

Therefore, I cannot populate the requested table and information based on the provided text. The document doesn't include:

1. Acceptance criteria or reported device performance metrics.
2. Sample sizes used for test sets.
3. Details about experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for training set.
9. How ground truth for the training set was established.

The document states that the device is a "Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only." This indicates its intended use, but not specific performance criteria or test results.

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